Cbd Pain Freeze Roll-on

Description

HEMP BOMBS CBD Pain Freeze Roll-On is a topical formulation designed for localized relief. It contains 4% menthol, which provides a cooling sensation upon application. The product is packaged in a 3 fluid ounce (89 mL) container, suitable for convenient use.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use. For adults aged 18 years and older, a thin layer of the medication should be applied to the affected areas. This application may be performed up to four times daily, ensuring that the dosage does not exceed the recommended frequency.

Contraindications

Use of this product is contraindicated in the following situations:

Application on the eyes or mucous membranes is prohibited due to the potential for irritation. It should not be applied to wounds, damaged, or irritated skin to avoid exacerbating these conditions. Additionally, individuals with a known allergy to Menthol or any of the listed ingredients should refrain from using this product to prevent allergic reactions.

In pregnant or breastfeeding individuals, the use of this product is contraindicated due to insufficient safety data.

While using this product, it is advised not to bandage or cover the area with any type of wrap, except for clothing, as this may alter the product's effectiveness. Furthermore, the use of heating pads, devices, or the application of external heat is contraindicated, as it may increase the risk of adverse effects.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is contraindicated for application on the eyes or mucous membranes, as well as on wounds, damaged, or irritated skin. It is essential to avoid use in individuals with a known allergy to Menthol or any of the other ingredients contained in the formulation.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Bandaging or covering the treated area with any type of wrap, except for clothing, is not recommended. Additionally, the use of heating pads, devices, or the application of external heat should be avoided during treatment.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any localized skin reactions occur, including but not limited to rash, itching, redness, irritation, pain, swelling, or blistering. Patients should also be instructed to stop use if their condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product is not recommended for use during pregnancy or while breastfeeding.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product may experience localized skin reactions, which can include rash, itching, redness, irritation, pain, swelling, and blistering. In such cases, patients are advised to discontinue use and consult a healthcare professional. Additionally, if any conditions worsen or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, medical advice should be sought.

This product is intended for external use only and should not be applied to the eyes, mucous membranes, or on wounds, damaged, or irritated skin. Patients with known allergies to Menthol or any of the listed ingredients should refrain from using this product.

It is important to note that this product is not recommended for use during pregnancy or while breastfeeding. Furthermore, it should be kept out of reach of children; in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Cbd Pain Freeze Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this product. The potential risks associated with the use of this product during pregnancy and lactation have not been established, and its safety profile in these populations remains unclear. Therefore, healthcare professionals are advised to counsel women of childbearing potential regarding the importance of avoiding this product during pregnancy and while breastfeeding.

Lactation

Lactating mothers are advised against the use of this product while breastfeeding. There is no available data on the excretion of this product in human milk or its effects on breastfed infants. Therefore, the potential risks to nursing infants and the lack of safety information necessitate caution.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, the use of this product is contraindicated due to potential teratogenic effects. No information regarding non-teratogenic effects is available in the insert. Additionally, there is no data provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients who are pregnant or breastfeeding should be informed that they should not use this product. It is essential to emphasize the importance of using the product only as directed to ensure safety and efficacy.

Healthcare providers should instruct patients not to bandage or cover the area of application with any type of wrap, except for clothing. Additionally, patients should be cautioned against using the product in conjunction with heating pads or other heating devices, as well as applying external heat to the treated area.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, away from direct sunlight, to maintain its efficacy and safety. Proper storage conditions are crucial for the product's stability and should be strictly adhered to by healthcare professionals.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cbd Pain Freeze Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)